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Open-Label Observational Pilot Study to Evaluate the Pharmacokinetics of Aripiprazole in Subjects With Bipolar 1 Disorder or Schizophrenia

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ClinicalTrials.gov Identifier: NCT02050854
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : January 31, 2014
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
The purpose of this study is to evaluate the pharmacokinetics of aripiprazole in subjects with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal aderence and are currently on treatment with oral aripiprazole.

Condition or disease
Bipolar 1 Disorder Schizophrenia Mental Disorder Nervous System Disorders

Detailed Description:

The purpose of this study is to evaluate the pharmacokinetics of aripiprazole in subjects with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal aderence and are currently on treatment with oral aripiprazole. This will be an open-label observational pilot trial to compare the PK profile of aripiprazole at Visit 1 of subjects who are receiving oral aripiprazole and who have the potential for suboptimal adherent behavior with their assigned medication.

Information obtained in the current trial will be used to inform the conduct of a randomized, open-label, parallel-group trial to assess between-group change from baseline adherence using PK sampling in subjects receiving oral aripiprazole with or without the MIND1 System (Protocol 316-13-211).


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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: An Open-Label Observational Pilot Study to Evaluate the Pharmacokinetics of Aripiprazole in Subjects With Bipolar 1 Disorder or Schizophrenia Who Have a History of Suboptimal Adherence and Are Currently on Treatment With Oral Aripiprazole
Study Start Date : December 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort
Observation
Subjects with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal adherence and are currently on treatment with oral aripiprazole



Primary Outcome Measures :
  1. Mean log transformed-area under the plasma concentration-time curve (AUC) at Visit 1 for subjects receiving oral aripiprazole, compared to historical values [ Time Frame: Visit 1 (Day 1) ]

Secondary Outcome Measures :
  1. Potential relationships between a clinically accepted indicator of non-adherent behavior, the Morisky 8-item Medication Adherence scale (MMAS-8), and aripiprazole concentrations in subjects [ Time Frame: Visit 1 (Day 1) to End of Study ]

Biospecimen Retention:   Samples With DNA
Whole blood, Plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion Criteria:

  • Male and female subjects 18 to 55 years of age (inclusive) at time of informed consent
  • Subjects with a primary current Axis 1 disorder of bipolar 1 disorder or schizophrenia as defined by DSM-IV-TR criteria, who have been treated in the outpatient setting for at least 2 months before screening
  • Subjects with a score of 1-7 on the Morisky 8-Item Medication Adherence Scale (MMAS-8)
  • Subjects with bipolar 1 disorder who have a YMRS score of 10 to 25 (inclusive), or subjects with schizophrenia who have a PANSS score of 60 to 90 (inclusive)
  • Subjects able to ingest oral medication
  • Subjects currently prescribed oral aripiprazole for either bipolar 1 disorder or schizophrenia, and who have not had any changes in their Aripiprazole regimen or dose over the last 2 weeks
  • Subjects who have an exacerbation of mood or psychotic symptoms when they are not receiving treatment or are noncompliant with treatment for their bipolar 1 disorder or schizophrenia
  • For subjects enrolled with bipolar 1 disorder, the current bipolar episode is mixed or manic (the current must not be a depressive episode)

Exclusion Criteria:

  • Subjects with a current Axis I (DSM-IV-TR) diagnosis other than bipolar 1 disorder or schizophrenia
  • Subjects with a current Axis II (DSM-IV-TR) diagnosis
  • Subjects not able to self-administer their medication
  • Subjects who reside in or attend a facility where medication is administered to them
  • Subjects who have a score of 0 or 8 on the Morisky 8-Item Medication Adherence Scale (MMAS-8)
  • Subjects who currently meet DSM-IV-TR criteria for substance dependence
  • Subjects with a history of inpatient hospitalization for any psychiatric reason within the past 2 months before screening
  • Subjects who have received any investigational product within the last 30 days
  • Subjects known to be allergic, intolerant, or unresponsive to prior treatment with Aripiprazole or other quinolinones
  • Subjects who, per investigator's judgment, are acutely psychotic or manic and/or exhibit symptoms currently requiring hospitalization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050854


Locations
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United States, California
Garden Grove, California, United States
United States, Georgia
Atlanta, Georgia, United States
Decatur, Georgia, United States
United States, Maryland
Rockville, Maryland, United States
United States, Washington
Bellevue, Washington, United States
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
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Study Director: Kimberly Largay, MD Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02050854     History of Changes
Other Study ID Numbers: 316-13-212
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: January 31, 2014
Last Verified: January 2014
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Aripiprazole
Treatment Adherence
Additional relevant MeSH terms:
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Aripiprazole
Disease
Schizophrenia
Mental Disorders
Nervous System Diseases
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists